UDI device identifier
Assure® Dose Normal (Level 1) Control Solution 500005
UDI device identifier 00015482500054 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482500054 |
|---|---|
| Brand name | Assure® Dose Normal (Level 1) Control Solution |
| Version or model | 500005 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | JJX |
| GMDN term | Glucose IVD, control |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jan 15, 2019 |
| Version date | Aug 24, 2026 |
| Description | Assure Dose Normal (Level 1) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Primary UPC# 015482500054 is used as the assigned UDI for the Class I device.) |
At a glance
- None MAUDE reports citing this UDI
- No Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: